Prevention of the Hepatic Sinusoidal Obstruction Syndrome by Means of Anticoagulants

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Colorectal Liver Metastases; Sinusoidal Obstruction Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT00885950

08-4-076

Details and patient eligibility

About

The purpose of the study is to determine whether anticoagulant use (i.e. salicylates, clopidogrel, low-molecular weight heparin, or coumarin derivates) is able to prevent the development of the sinusoidal obstruction syndrome secondary to oxaliplatin-based neoadjuvant chemotherapy in patients suffering from colorectal liver metastases.

Full description

Surgical resection remains the only curative treatment for patients suffering from colorectal liver metastases, but only 15-25% of patients are initially eligible for resection. The majority of patients suffering from colorectal liver metastases receives chemotherapy prior to liver surgery in order to downsize the colorectal liver metastases. Preoperative treatment with oxaliplatin-based chemotherapy is related to sinusoidal injury, the so-called sinusoidal obstruction syndrome. Patients with histologically proven sinusoidal injury undergoing liver surgery have a higher risk of post-resectional morbidity. Damage to the hepatic sinusoids is a key factor for the development of the sinusoidal obstruction syndrome. Anticoagulants (i.e. salicylates, clopidogrel, low-molecular weight heparin, or coumarin derivates) might be able to prevent this damage and, consequently, the development of the sinusoidal obstruction syndrome in patients suffering from colorectal liver metastases treated with neoadjuvant chemotherapy.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age > 18 years
• colorectal liver metastases that are eligible for resection
• operated from January 2008 up until December 2009 at Maastricht University Medical Centre

Exclusion criteria

• irresectable colorectal liver metastases

Trial design

80 participants in 1 patient group

Colorectal liver metastases

Description:

Patients with colorectal liver metastases undergoing partial hepatic resection who were preoperatively treated with either neoadjuvant chemotherapy or not and/or anticoagulants or not